Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Whole Slide Imaging System
510(k) Number K190332
Device Name Aperio AT2 DX System
Applicant
Leica Biosystems Imaging, Inc.
1360 Park Center Dr.
Vista,  CA  92081
Applicant Contact Christine Kishi
Correspondent
Leica Biosystems Imaging, Inc.
1360 Park Center Dr.
Vista,  CA  92081
Correspondent Contact Christine Kishi
Regulation Number864.3700
Classification Product Code
PSY  
Date Received02/14/2019
Decision Date 05/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-